Mr.John E. Lincoln

Regulated CGMP companies must develop / implement a formal CSA, Computer Software Assurance program, addressing AI where appropriate, per the FDA's recent Guidance Document. Software and related hardware design, development, verification and validation is dif ...

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...

The FDA's DHF, DMR, DHR, and the EU's MDR TF/DD - Meeting their different purposes; future trends. This webinar will examine the existing requirements for the US  FDA's DHF -- including its derivative documents, the DMR and DHR, and the identical ISO 13485 7. ...

The US FDA, a has published their QMSR 21 CFR 820, to replace the previous QSR 21 CFR 820, Medical Devices, implemented February 02, 2016. They also released their new Device Inspection Manual 7382.850, on the same date, with the focus on Patient / User Risk M ...

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Due to the growth of the cybersecurity threat to electroni ...

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...

Verification and validation requirements have always been part of the US FDA’s cGMPs.  However, with increasing technology, both industry, and regulatory agencies' expectations have increased.  Recent high-profile field problems indicate that V&V activities ar ...

In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested fi ...